Departmental Resources for Research Development Beverly Collins - - PowerPoint PPT Presentation

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Beverly Collins Amber Nestor Erin Schubert

Departmental Resources for Research Development

TOPICS

Beverly Collins: Grant-preparation and submission Amber Nestor: Budget development Erin Schubert: Protocol development

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Putting together a grant

 I can help with:

 Funding sources  Biographical sketch  Resources descriptions  Collecting letters, signatures  Information  Noodge, go-between  Proofreading

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Submitting a Proposal

 2 ways a grant may be submitted

1.

P.I. submits the grant directly to the funding agency.

2.

A representative of Penn submits the grant to the funding agency.

 Funding agency designates which

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Penn’s review process

 EVERY external-funding proposal must be

entered into Penn’s online grant application system (PennERA/PD)

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PD (Proposal Development)

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Penn’s review process

 For non-NIH proposals, use the application provided

by the funding agency and upload to PD for institution review and approval.

 The funding agency will indicate whether the

application is to be submitted by an institutional

• fficial.

 (NIH proposals are created from the PD record; you

do not use the NIH application package.)

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Penn’s review process

 I can help you set up the proposal in PD  You don’t need to enter the budget info

into PD. We have people to do that for you.

 Amber Nestor handles all RSNA grants

and most resident proposals.

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 The administrative (i.e. budget) part of

the proposal should be submitted for Penn review 1-2 weeks before deadline.

RSNA Proposal Instructions

 RSNA deadline: Jan 15, 2019  Penn budget deadline: Jan 8  You will need a signature from Penn

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RSNA Signature page

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RSNA Signature page

 You will enter names of signatories to

RSNA application site, then download the signature page.

 You, your advisor, and the chair sign,

then upload to PD.

 When budget is approved, Penn rep will

sign, and you can download completed page from PD and upload it to RSNA site.

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Take-home points

 Grant-writing takes time and has a lot

• f pieces

 There is a Penn review process before

submitting to sponsor

 There are people here to help  Let me know as soon as you decide to

apply for a grant

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Speaking of budgets…

 The First Bank of the United States

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128 South 3rd Street

Greek revival

Speaking of budgets…

 The Second Bank of the United States

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420 Chestnut Street

The structure is open to the public free of charge and serves as an art gallery, housing a large collection of portraits of prominent early Americans painted by Charles Willson Peale and many others.

Greek revival

Budget Amber Nestor

Grant Manager

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Budget

 Contact – 6-8 weeks prior to due

date

 Send guidelines/funding

announcements for review

 Budget must be finalized 10-14

business days prior to due date

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What should be included?

 Personnel: % effort for each

investigator

 Imaging: how many of what kinds of

scans

 Supplies, equipment, animals, etc.  Travel, for presenting results  I can help with this if you are unsure!!

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What else do you need to do?

 Budget justifications – if these are

required, they must have detailed information about what you’re asking for! I can send samples of justifications if you are lost!

 Pay close attention to due dates for

grants – specifically NIH grants!

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Congrats! You’re funded… now what?

 All funds come through Radiology  No pre-award costs are allowed, unless

noted in the NOGA or award letter

 Spending cannot occur prior to start

date of grant

 Account numbers are issued once the

grant is awarded.

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Finally….

 Please DO NOT submit grants on your

• wn!! Every grant that you apply for

must have institutional review.

 Some sponsors require signature pages  NIH requires submission be done by an

authorized University official!

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Protocol Development Erin Schubert

Administrative Director, PET Center

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Protocol Development

 Idea  Grant  Protocol  Start planning your protocol from the

beginning

 Many sections of the protocol will

• verlap with required grant sections

 IRB submission and review can take 6-8

weeks from submission to approval

 IND submission can take additional time

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Plan Your Grant

 Planning for the human subjects

protocol early will aid in grant preparation

 Helps motivate grant aims  Developing a budget and budget

justifications

 Evaluating necessary staff and co-

investigators requiring funding

 Human subject protections write up

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Strategic Planning

 NIH grants often require IRB approval

as part of JIT submissions

 Avoid delays in study start up once you

receive funding

 Institutional opportunities may exist to

start collecting pilot data prior to notice

• f award

 Multiple UPenn regulatory committees

(IRB, RRSC, CTSRMC)

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Protocol Building Blocks

 Background and Scientific Rationale

 What is the purpose of the proposed

research? What is the value added?

 Objectives

 What do you hope to learn from the

proposed research?

 Study Design

 What is your plan for meeting the study

• bjectives?

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Protocol Building Blocks

 Participant selection

 What subject population do you plan to

study?

 Recruitment

 How will you get access to your subject

population? Does this require additional collaborators?

 Investigational agent?

 Does the study require an IND?

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Protocol Building Blocks

 Procedures

 What research procedures will the study

include? Who will perform the procedures?

 Risks  Statistical Plan

 How will you analyze your study results?

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IND Considerations

 Does your study involve an

investigational drug?

 Is the drug currently made at Penn or

does it need to be developed?

 Will your study require a new IND or

does Penn already have an active IND?

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IND Building Blocks

 Background and Investigational Plan  Pharmacology and Toxicology  Previous Human Experience  Biodistribution and Dosimetry  Chemistry, Manufacturing and Controls  Protocol and Investigator Information

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Key Contacts for Protocol/IND

 Erin Schubert – Protocol, IND,

Regulatory document development and submission

 Kathleen Thomas and Patty Atkinson-

Radiology IND support office, handles all IND submissions and monitoring

 Sharon Lee – Cyclotron contact for

development of drug synthesis, validation testing and CMC creation

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Key Links - Research at Penn

 IRB : https://hsera.apps.upenn.edu  RRSC:

https://ehrs.upenn.edu/radiation- safety/topics/research

 CTSRMC: http://www.ctsrmc.org/  CAMRIS:

https://www.med.upenn.edu/camris/

 OCR: https://www.med.upenn.edu/ocr/

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Key Links - Research at Penn

 PennERA:

https://www.pennera.upenn.edu/

 RSNA grants:

https://www.rsna.org/en/research/fundi ng-opportunities/research-grants



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People in department

 Beverly Collins: grant funding, proposal development  Amber Nestor: budget development  Erin Schubert: protocol development  Kathleen Thomas: research coordinator requests  Bill D’Arcy : Business Administrator for grants, pre-

and post-award

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